UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032783 |
|---|---|
| Receipt number | R000037399 |
| Scientific Title | Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2018/11/29 10:07:20 |
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Basic information
Public title
Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study
Acronym
Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome(PR-NAFLD)
Scientific Title
Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study
Scientific Title:Acronym
Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome(PR-NAFLD)
Region
| Japan |
Condition
Condition
polycystic ovary syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.
Basic objectives2
Others
Basic objectives -Others
To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of NAFLD (Alanine aminotransferase (ALT) > 19 IU/L)
Key secondary outcomes
Risk factors of NAFLD
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Meet all of the following:
1) Women visited the Department of Gynecology in our Center from January 1, 2000 to September 30, 2016.
2) Women with confirmed diagnosis of polycystic ovary syndrome.
3) ALT data available
Key exclusion criteria
Fall under any of the following:
1) Missing data of body height, weight and BMI
2) Women with history of liver diseases
3) Pregnant women
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Yamaguchi |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
+81-75-641-9161
kyamaguc@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Minato |
Organization
Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name
Department of Preventive Medicine
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
+81-75-641-9161
Homepage URL
sminato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037399
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| Research case data | |
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